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Orange Book product · Generic (ANDA)

PRAMIPEXOLE DIHYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE

Generic (ANDA)ANDA 077854DISCN NATCO
View PRAMIPEXOLE DIHYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Oct 08, 2010

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 08, 2010

    15 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Strength

0.125MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 077854

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PRAMIPEXOLE DIHYDROCHLORIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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